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Enabling online determination of the size-dependent RNA content of lipid nanoparticle-based RNA formulations

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 2021-12, Vol.1186, p.123015-123015, Article 123015

2021

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Dissolution Profile Similarity Assessment—Best Practices, Decision Trees and Global Harmonization

The AAPS journal, 2023-04, Vol.25 (3), p.44-44, Article 44

2023

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Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization

Journal of pharmaceutical sciences, 2018-01, Vol.107 (1), p.34-41

2018

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Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report

The AAPS journal, 2018-08, Vol.20 (6), p.93-93, Article 93

2018

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Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms

The AAPS journal, 2017-11, Vol.19 (6), p.1537-1549

2017

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Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations

The AAPS journal, 2022-03, Vol.24 (3), p.50-50, Article 50

2022

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Developing Clinically Relevant Dissolution Specifications for Oral Drug Products-Industrial and Regulatory Perspectives

Pharmaceutics, 2019-12, Vol.12 (1), p.19

2019

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Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series

Pharmaceutics, 2022-05, Vol.14 (5), p.1010

2022

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Industry's perspective on challenges assessing the in vivo impact of removing titanium dioxide (TiO2) from drug products

Journal of pharmaceutical sciences, 2024-08

2024

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Commentary on “The Effect of Sampling Cannula on In Vitro Dissolution Testing with USP Paddle Method”

The AAPS journal, 2024-06, Vol.26 (4), p.73, Article 73

2024

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Dissolution and Translational Modeling Strategies Enabling Patient-Centric Drug Product Development: the M-CERSI Workshop Summary Report

The AAPS journal, 2018-05, Vol.20 (3), p.60-60, Article 60

2018

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Biodistribution of [89Zr]DFO-Maleimide-VLP-1 in Wistar Rats by Positron Emission Tomography (PET)

Nuclear medicine and biology, 2023-11, Vol.126-127, p.108667, Article 108667

2023

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In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When—Workshop Summary Report

The AAPS journal, 2020-05, Vol.22 (4), p.74-74, Article 74

2020

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Multi-dimensional plug-and-play liquid chromatography-native ion mobility mass spectrometry method for the analysis of biotherapeutics

International journal of mass spectrometry, 2022-01, Vol.471, p.116725, Article 116725

2022

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Development of an ultra‐high‐performance liquid chromatography‐charged aerosol detection/UV method for the quantitation of linear polyethylenimines in oligonucleotide polyplexes

Journal of separation science, 2020-10, Vol.43 (20), p.3876-3884

2020

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Assessing the Impact of Different Light Sources on Product Quality During Pharmaceutical Drug Product Manufacture – Fluorescent Versus Light-Emitting Diode Light

Journal of pharmaceutical sciences, 2020-11, Vol.109 (11), p.3360-3369

2020

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Mechanistic understanding of abnormal reverse phase chromatographic behavior of basic analytes in the presence of sodium dodecyl sulfate

Journal of Chromatography A, 2019-06, Vol.1595, p.108-116

2019

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DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS

The AAPS journal, 2022-05, Vol.24 (3), p.54-54, Article 54

2022

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Ethanolamine Ammonia-Lyase Has a “Base-On” Binding Mode for Coenzyme B12

Archives of biochemistry and biophysics, 1999-10, Vol.370 (1), p.138-141

1999

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Biowaiver Applications in Support of a Polymorph During Late-Stage Clinical Development of Verubecestat—Current Challenges and Future Opportunities for Global Regulatory Alignment

The AAPS journal, 2019-12, Vol.22 (1), p.17-17, Article 17

2019

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Probing Protein Conformation Destabilization in Sterile Liquid Formulations through the Formation of 3,4-Dihydroxyphenylalanine

Molecular pharmaceutics, 2020-10, Vol.17 (10), p.3783-3793

2020

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Concerning the stability of benzyl alcohol: formation of benzaldehyde dibenzyl acetal under aerobic conditions

Journal of pharmaceutical and biomedical analysis, 2004-03, Vol.34 (5), p.957-962

2004

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Identification of cis-Ethanesemidione as the Organic Radical Derived from Glycolaldehyde in the Suicide Inactivation of Dioldehydrase and of Ethanolamine Ammonia-Lyase

Biochemistry (Easton), 2000-05, Vol.39 (20), p.6250-6257

2000

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Development and validation of an automated extraction method (accelerated solvent extraction®) and a reverse-phase HPLC analysis method for assay of ivermectin in a meat-based chewable formulation

Journal of pharmaceutical and biomedical analysis, 2003-04, Vol.31 (6), p.1177-1183

2003

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Development of an automated and High throughput UHPLC/MS based workflow for cleaning verification of potent compounds in the pharmaceutical manufacturing environment

Journal of pharmaceutical and biomedical analysis, 2020-09, Vol.188, p.113401-113401, Article 113401

2020

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Enabling online determination of the size-dependent RNA content of lipid nanoparticle-based RNA formulations

Dissolution Profile Similarity Assessment—Best Practices, Decision Trees and Global Harmonization

Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization

Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report

Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms

Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations

Developing Clinically Relevant Dissolution Specifications for Oral Drug Products-Industrial and Regulatory Perspectives

Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series

Industry's perspective on challenges assessing the in vivo impact of removing titanium dioxide (TiO2) from drug products

Commentary on “The Effect of Sampling Cannula on In Vitro Dissolution Testing with USP Paddle Method”

Dissolution and Translational Modeling Strategies Enabling Patient-Centric Drug Product Development: the M-CERSI Workshop Summary Report

Biodistribution of [89Zr]DFO-Maleimide-VLP-1 in Wistar Rats by Positron Emission Tomography (PET)

In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When—Workshop Summary Report

Multi-dimensional plug-and-play liquid chromatography-native ion mobility mass spectrometry method for the analysis of biotherapeutics

Development of an ultra‐high‐performance liquid chromatography‐charged aerosol detection/UV method for the quantitation of linear polyethylenimines in oligonucleotide polyplexes

Assessing the Impact of Different Light Sources on Product Quality During Pharmaceutical Drug Product Manufacture – Fluorescent Versus Light-Emitting Diode Light

Mechanistic understanding of abnormal reverse phase chromatographic behavior of basic analytes in the presence of sodium dodecyl sulfate

DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS

Ethanolamine Ammonia-Lyase Has a “Base-On” Binding Mode for Coenzyme B12

Biowaiver Applications in Support of a Polymorph During Late-Stage Clinical Development of Verubecestat—Current Challenges and Future Opportunities for Global Regulatory Alignment

Probing Protein Conformation Destabilization in Sterile Liquid Formulations through the Formation of 3,4-Dihydroxyphenylalanine

Concerning the stability of benzyl alcohol: formation of benzaldehyde dibenzyl acetal under aerobic conditions

Identification of cis-Ethanesemidione as the Organic Radical Derived from Glycolaldehyde in the Suicide Inactivation of Dioldehydrase and of Ethanolamine Ammonia-Lyase

Development and validation of an automated extraction method (accelerated solvent extraction®) and a reverse-phase HPLC analysis method for assay of ivermectin in a meat-based chewable formulation

Development of an automated and High throughput UHPLC/MS based workflow for cleaning verification of potent compounds in the pharmaceutical manufacturing environment

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